COVID-19 Trials, Research Evolves at Record Pace

COVID-19 Trials, Research Evolves at Record Pace

April 15, 2020

Efforts range from treatments to biology of the virus to impact on high-risk communities.

While helping lead several national clinical trials to identify COVID-19 therapeutics, investigators at Vanderbilt University Medical Center are organizing a host of studies to better clarify the basic biology of the SARS-CoV-2 virus and to understand COVID-19’s impact on specific patient populations.

The collaborative research efforts are coming together in record time. “It’s going at about as fast of a pace as I’ve ever seen,” said Brian Rini, M.D., chief of clinical trials at Vanderbilt-Ingram Cancer Center.

“Coordinating clinical trials that organizations usually do over months and years, we’re doing over days.”

“Coordinating clinical trials that organizations usually do over months and years, we’re doing over days.”

The COVID-19 and Cancer Consortium

To collect data necessary to understand the unique effects of COVID-19 on cancer patients, the COVID-19 and Cancer Consortium was launched on March 20, and already there are more than 80 participating U.S. institutions.

The national collaborative effort, initiated by Rini and Jeremy Warner, M.D., an associate professor of biomedical informatics at Vanderbilt, uses a REDCap survey to capture information on cases of SARS-CoV-2 infection in patients with active cancer. The survey gathers about 100 data points per patient, with data entry taking less than 10 minutes per patient.

“We’ve tried to find the balance between wanting to collect every single data point on a given patient, which might take an hour per patient, versus having the survey not capture enough information,” Rini said. “If it’s too onerous, people won’t do it, they’re too busy clinically. But if it’s not detailed enough, then you’ve done all this work, but you won’t get as much out of it as you could.”

“It’s up and running and now we’re just gathering data from sites,” Rini said. “It’s a huge resource. We want to understand whether cancer patients are at particular risk. Do they have different outcomes? What are the factors? Is there geographic variation? I could list 100 questions we are interested in answering.”

Translational Efforts

To better understand the biology of SARS-CoV-2 infections, Vanderbilt has also established translational protocols to collect an exhaustive array of samples from COVID-19 patients.

“There are basic science questions that are unknown regarding the biology of the disease and the different patient outcomes that will eventually inform therapeutics,” Rini said. “We want to utilize patient samples to understand, for example, the immune response to the virus, and why certain people get very sick but many to most are asymptomatic.”

The translational effort spans departments across the medical center and involves both inpatients and outpatients and “every sample you can think of,” Rini said. “That knowledge base is really invaluable.”

Therapeutics Trials

The Adaptive COVID-19 Treatment Trial, launched in February, is a double-blind, placebo-controlled, randomized study to evaluate the safety and efficacy of remdesivir in hospitalized adults diagnosed with COVID-19. Remdesivir is a nucleoside analog that inhibits coronavirus replication.

The ORCHID (Outcomes Related to COVID-19 Treated with Hydroxychloroquine Among Inpatients with Symptomatic Disease) trial is for the treatment of adults hospitalized with COVID-19. The first patients were enrolled at Vanderbilt, which is one of 44 participating sites.

In addition, Vanderbilt is participating in a national trial opening soon to evaluate hydroxychloroquine as prophylaxis for COVID-19 in healthcare workers.

“Health care workers in high-risk situations, such as the emergency room and the ICU, are going to come into contact with COVID-19 patients on a regular basis,” Rini said. “For the pre-exposure prophylaxis study, we want to determine whether hydroxychloroquine can prevent infection in this high-risk group.”